510(k) · Cleared
ClearedSterilucent Process Challenge Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilucent, Inc. · FRC Indicator, Biological Sterilization Process
Cleared on Oct 31, 2014 as substantially equivalent to K092906 (STERIS Corporation, 2009) after a 164-day review. Its family tree reaches back 4 generations to 2005. 3 later devices descend from it.
- Decided
- Oct 31, 2014
- Review
- 164 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K042450 (2005). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK042450 Sterrad NX Challenge PackAdvanced Sterilization Products · 2005
- 3 generations backK051643 Sterrad Sterilizer Cyclesure Test PackAdvanced Sterilization Products · 2005
- 2 generations backK073618 Verify Sirius Biological Indicator Challenge PackSTERIS Corporation · 2009
- 1 generation backK092906 Verify Biological Indicator Challenge Pack for Vaporized VH202…STERIS Corporation · 2009
- This deviceK141312 Sterilucent Process Challenge DeviceSterilucent, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK192001 Sterilucent self-Contained Biological Indicator, Sterilucent Lumen…Sterilucent, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK233814 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge…3M Company · 2024
- Descendant · 3 generations on · 0 of its ownK241542 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge…3M Company · 2024
Most influential descendants
Showing 3 of 3 · See all- K192001Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process…Sterilucent, Inc. · 2019 · cites it directly2descendants
- K2338143M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™…3M Company · 2024 · 2 generations on1descendant
- K2415423M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)3M Company · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K042450 | Sterrad NX Challenge Pack | Advanced Sterilization Products | 2005 | — |
| −3 | K051643 | Sterrad Sterilizer Cyclesure Test Pack | Advanced Sterilization Products | 2005 | — |
| −2 | K073618 | Verify Sirius Biological Indicator Challenge Pack | STERIS Corporation | 2009 | — |
| −1 | K092906 | Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization | STERIS Corporation | 2009 | — |
| 0 (this device) | K141312 | Sterilucent Process Challenge Device | Sterilucent, Inc. | 2014 | — |
| +1 | K192001 | Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle… | Sterilucent, Inc. | 2019 | — |
| +2 | K233814 | 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack… | 3M Company | 2024 | — |
| +3 | K241542 | 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack… | 3M Company | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRC device
- #1 K250044 Celerity 5 HP Biological Indicator (LCB052)…score 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K092906 | Verify Biological Indicator Challenge Pack for Vaporized VH202 SterilizationSummary page 5…evice Class: Class I Product Code: FRC (21 CFR 880.2800) Predicate Device Steris Verify Biological Indicator Challenge Pack for Vaporized H202 Sterilization Processes (K092906) Device Description The Sterilucent PCD-L and PCD-NL are pre-assembled devices that consist of a Sterilucent Self-Contained Bio… | 2009 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192001 | Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process… | 2019 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K192001 (Sterilucent, Inc., 2019) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K092906.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FRC
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRC
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRC
8so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRC
9in 2025
MAUDE reports naming product code FRC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 83 | 0 | 100 |
| 2008 | 1 | — | 0 | 60 |
| 2009 | 6 | 183 | 1 | 45 |
| 2010 | 4 | 165 | 0 | 57 |
| 2011 | 6 | 118 | 0 | 37 |
| 2012 | 9 | 178 | 2 | 46 |
| 2013 | 4 | 260 | 2 | 39 |
| 2014 | 13 | 174 | 0 | 51 |
| 2015 | 3 | 130 | 0 | 182 |
| 2016 | 2 | — | 0 | 482 |
| 2017 | 10 | 130 | 0 | 182 |
| 2018 | 18 | 97 | 0 | 22 |
| 2019 | 5 | 88 | 0 | 30 |
| 2020 | 10 | 150 | 0 | 16 |
| 2021 | 5 | 107 | 0 | 10 |
| 2022 | 5 | 193 | 4 | 9 |
| 2023 | 6 | 190 | 1 | 20 |
| 2024 | 8 | 105 | 0 | 22 |
| 2025 | 6 | 29 | 0 | 9 |
| 2026 | 1 | — | 8 | — |
What is it indicated for?
The Sterilucent Process Challenge Device PCD-L for Lumen Cycle is used for performance qualification of the Sterilucent PSD-85 sterilizer during initial installation, after relocation, major repairs or malfunctions, or after sterilization process failures. The Sterilucent PCD-L may also be used for routine monitoring of the PSD-85 Sterilizer Lumen Cycle. The Sterilucent Process Challenge Device PCD-NL for Non-Lumen Cycle is used for performance…
Read the full statement (98 words)
The Sterilucent Process Challenge Device PCD-L for Lumen Cycle is used for performance qualification of the Sterilucent PSD-85 sterilizer during initial installation, after relocation, major repairs or malfunctions, or after sterilization process failures. The Sterilucent PCD-L may also be used for routine monitoring of the PSD-85 Sterilizer Lumen Cycle.
The Sterilucent Process Challenge Device PCD-NL for Non-Lumen Cycle is used for performance qualification of the Sterilucent PSD-85 Sterilizer during initial installation, after relocation, major repairs or malfunctions, or after sterilization process failures. The Sterilucent PCD-NL may also be used for routine monitoring of the PSD-85 Sterilizer Non-Lumen Cycle.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141312: Sterilucent Process Challenge Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141312
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026